Effect of Inhalation of Mint Oil on Vital Signs and O2 Saturation in neurosurgery Patient Hospitalized in Intensive Care Unit
Design
The study will be performed as a single-blind randomized clinical trial (researcher) in the intensive care unit of Qom Health Donors Hospital. Participants will be 80 neurosurgery patients who will be randomly assigned to two intervention and control groups.
Settings and conduct
The present study will be performed in the intensive care unit of Qom Health Donors Hospital. Participants will be 80 neurosurgery patients. Vital signs and participants' blood oxygen saturation percentage will be recorded and compared immediately before the intervention, 15, 30 minutes, and 1, 3, and 6 hours after the intervention. Two identical jars are prepared from peppermint extract and distilled water with a dye in a sterile manner and only labels "A" and "B" are placed on them. Blinding will also be used in statistical analysis.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1- Age over 18 years and less than 50 years
2- No history of allergy to a particular substance
3- Awareness level above 13 according to Glasgow criteria
4- No history of addiction
5 - No underlying disease (diabetes, hypertension, chronic heart failure, respiratory failure and renal failure)
6- No endotracheal tube or 24 hours at the beginning of its removal
7- Stability of vital signs at least 12 hours before the intervention
Intervention groups
In the intervention group, 0.2 ml of 10% peppermint extract with 10 ml of distilled water will be nebulized through the nebulizer mask for 15 minutes with oxygen and in the control group, 0.2 ml of green colored distilled water with 10 ml of distilled water will be nebulized through the nebulizer mask for 15 minutes with oxygen.
Main outcome variables
vital signs (blood pressure, heart rate and respiration) and blood oxygen saturation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210131050189N1
Registration date:2021-05-13, 1400/02/23
Registration timing:prospective
Last update:2021-05-13, 1400/02/23
Update count:0
Registration date
2021-05-13, 1400/02/23
Registrant information
Name
Raziyeh Ghafouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3335 4520
Email address
ghafouri@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-16, 1400/02/26
Expected recruitment end date
2021-10-23, 1400/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Inhalation of Mint Oil on Vital Signs and O2 Saturation in neurosurgery Patient Hospitalized in Intensive Care Unit
Public title
Effect of Inhalation of Mint Oil on Vital Signs and O2 Saturation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years and under 50 years
No history of allergy to a particular substance-
Awareness level above 13 according to Glasgow criteria
No history of addiction
No underlying disease (diabetes, high blood pressure, chronic heart failure, respiratory failure and kidney failure)-
No endotracheal tube or 24 hours after extubation
Stability of vital signs at least 12 hours before the extubation
Exclusion criteria:
Any sudden change in vital signs and general condition during the intervention that is a sign of intolerance to aromatherapy.
Any change in the patient's breathing pattern during the intervention
Change in the patient's medication during the intervention up to 6 hours after the intervention
Complications after surgery such as severe pain, active bleeding, or infection
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Restricted randomization by Random allocation rule will be used. Random allocation will be done with white and black cards. For allocation concealment, Sequentially numbered, opaque envelopes, sealed envelopes will be used.
Before the intervention, 40 white cards and 40 black cards are placed in an envelope and taken out, respectively. The order of the removed cards from 1 to 80 is placed on the special envelopes for sampling. With the order of the samples, a special envelope is opened and it is placed in group A or B based on the color of the patient's card. If the card taken out of the envelope is white, the patient is in group A, and if the card is black, the patient is in group B.
Blinding (investigator's opinion)
Single blinded
Blinding description
Two identical medicine bottles are prepared from peppermint extract and a medicine bottle containing distilled water with a colored substance in a sterile form. Placed on them. For aromatherapy in group A, a medicine glass labeled "A" will be used and in group B, a medicine glass labeled "B" will be used. Also, in statistical analysis, blinding will be used, in which the statistical consultant will be unaware of the two groups of intervention and control, and the two groups will be introduced to him as groups A and B.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Pharmacy and Nursing & Midwifery- Shahid Beheshti University of Medical Sciences (Biomedic
Street address
Vali-Asr Avenue, Cross of Vali-Asr Avenue and Hashemi Rafsanjani (Neiaiesh) Highway, Opposite to Rajaee Heart Hospital, Tehran
City
Tehran
Province
Tehran
Postal code
1996835119
Approval date
2021-05-02, 1400/02/12
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1400.014
Health conditions studied
1
Description of health condition studied
neurosurgery Patient Hospitalized in Intensive Care Unit
ICD-10 code
S06.4X
ICD-10 code description
Epidural hemorrhage
2
Description of health condition studied
neurosurgery Patient Hospitalized in Intensive Care Unit
ICD-10 code
S06.5X
ICD-10 code description
Traumatic subdural hemorrhage
3
Description of health condition studied
neurosurgery Patient Hospitalized in Intensive Care Unit
ICD-10 code
S06.2
ICD-10 code description
Diffuse traumatic brain injury
Primary outcomes
1
Description
Blood pressure
Timepoint
6 hours after intervention
Method of measurement
blood pressure monitoring
2
Description
O2 Saturation
Timepoint
6 hours after intervention
Method of measurement
pulse oximetry
3
Description
pulse rate
Timepoint
6 hours after intervention
Method of measurement
heart rate monitoring
4
Description
respiratory rate
Timepoint
6 hours after intervention
Method of measurement
respiratory rate monitoring
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 0.2 ml of 10% peppermint extract with 10 ml of distilled water will be nebulized through the nebulizer mask for 15 minutes with oxygen.
Category
Treatment - Other
2
Description
Control Group: 0.2 ml of green distilled water with 10 ml of distilled water will be nebulized through the nebulizer mask for 15 minutes with oxygen.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Qom Health Donors Hospital
Full name of responsible person
Ali Fooladvand
Street address
Qom Health Donors Hospital
City
Ghoum
Province
Ghoum
Postal code
1996835119
Phone
+98 21 8820 2520
Email
afoolad133@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
shahid beheshti univercity of medical science
Street address
Vali-Asr Avenue, Cross of Vali-Asr Avenue and Hashemi Rafsanjani (Neiaiesh) Highway, Opposite to Rajaee Heart Hospital, Tehran
City
tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8820 2520
Email
raziehghafouri@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
no thing
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Raziyeh Ghafouri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Vali-Asr Avenue, Cross of Vali-Asr Avenue and Hashemi Rafsanjani (Neiaiesh) Highway, Opposite to Rajaee Heart Hospital, Tehran
City
tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8820 2520
Email
raziehghafouri@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Raziyeh Ghafouri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Vali-Asr Avenue, Cross of Vali-Asr Avenue and Hashemi Rafsanjani (Neiaiesh) Highway, Opposite to Rajaee Heart Hospital, Tehran
City
tehran
Province
Tehran
Postal code
1996835119
Phone
009888202520
Email
raziehghafouri@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
raziyeh Ghafouri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Vali-Asr Avenue, Cross of Vali-Asr Avenue and Hashemi Rafsanjani (Neiaiesh) Highway, Opposite to Rajaee Heart Hospital, Tehran
City
tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8820 2520
Email
raziehghafouri@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
After defending the dissertation and publishing the article
To whom data/document is available
For researchers working in academic and scientific institutions
Under which criteria data/document could be used
For further research
From where data/document is obtainable
By email of the co responder author:
raziehghafouri@gmail.com
What processes are involved for a request to access data/document
Ask the responsible author in an email. Mention the purpose and location of the research in the email. The co responder author will be answered within two weeks